Status:
ACTIVE_NOT_RECRUITING
XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
Lead Sponsor:
XBiotech, Inc.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This trial will include 2 portions (phase 1 and phase 2). The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by...
Detailed Description
Study Title: A Phase I/II randomized, double-blind, placebo-controlled trial (1-BETTER) examining XB2001 (anti-IL-1⍺ True Human antibody) in combination with ONIVYDE + 5-FU/LV (+folinic acid) in advan...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumor V1.1
- Documented disease progression after one prior gemcitabine-based therapy OR one FOLFIRINOX and gemcitabine combination therapy
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 or Karnofsky performance status (KPS) ≥ 70
- Adequate hepatic, renal and bone marrow function
Exclusion
- Clinically significant decrease in performance status (medical records) within 2 weeks of intended first dose administration
- Clinically significant GI disorders
- Severe arterial thromboembolic events less than 6 months before inclusion
- Prior Whole Brain Radiation Therapy (WBRT)
- Evidence of brain metastases
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (defined as ≥ 160/100 mm Hg)
- Use of strong CYP3A4 inducers or inhibitors and/or UGT1A1 inhibitors within 14 days prior to Visit 1/Baseline visit.
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04825288
Start Date
May 27 2021
End Date
June 10 2025
Last Update
February 28 2025
Active Locations (28)
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1
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
2
Disney Family Cancer Center at Providence St. Joseph Medical Center
Burbank, California, United States, 91505
3
TOI Clinical Research
Cerritos, California, United States, 90703
4
Providence St. Joseph Heritage - Fullerton, CA
Fullerton, California, United States, 92835